DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 05/13/2025 has been entered.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 1, and any claim which is dependent from claim 1 (claims 4 and 6-7), is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. The claim now requires all of the layers satisfy a condition (4) which is a specimen with a thickness of 1.20 ± 0.01 mm has a chromaticity satisfying ∆b*≥ 17.0. This limitation is derived from examples 5-7. However, these examples do not support all values above 17.0. Instead the examples range from 17.0 (layer F from Example 5) to 20.8 (layer L from Example 7). Furthermore, there does not appear to be a description from the rest of the specification indicating that the ∆b* can be greater than 20.8 (21, 25, or 35, etc). As such, the claim is rejected for failing to comply with the written description requirement such that the specification does not support any values for ∆b* above 20.8.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 1, and any claim which is dependent from claim 1 (claims 4 and 6-7), is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Claim 1 requires the dental mill blanks to contain an inorganic pigment, in a content range of 0.070 to 0.100 parts by mass relative to 100 parts by mass of the inorganic filler. The claim further requires the dental mill blanks to further include a layered structure comprising 2 or more layers. However, it is unclear if each of the layers in the layered structure require the inorganic pigment in the claimed range or if only one of the layers is required to have the content of the inorganic pigment as claimed. As such, the claim is rejected for failing to point out and distinctly claim the subject matter that is applicant’s invention. For the purposes of examination, the claim is to be interpreted as at least one of the layers in the layered structure comprises the inorganic pigment in the content range of 0.070 to 0.100 parts by mass relative to 100 parts by mass of the inorganic filler, as this appears to be applicant’s intent (Instant Specification, PGPUB, Paragraph [0029]).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1, 4 and 6-7 are rejected under 35 U.S.C. 103 as being unpatentable over Okada et al. (US 2015/0182315) in view of Goto et al. (US 2017/0056140).
Regarding claim 1, Okada teaches a method of producing a dental mill blank and a dental mill blank produced by the method (Pg. 1, Paragraph [0001]). The dental mill blank is formed from an inorganic filler which is subjected to press molding and a polymerizable monomer-containing composition and allowing the polymerizable monomer to polymerize and cure (Pg. 2, Paragraph [0029]). The inorganic filler may be any known inorganic particle which are usable as fillers in dental composite resins, including silica (Pg. 2, Paragraph [0030]). Additionally, the fillers are appropriately selected in order to achieve physical properties that closely resemble that of natural teeth (Pg. 2, Paragraph [0031]). The inorganic fillers are further taught to have an average particle size in the range of 0.001 to 10 microns (1 to 10,000 nm) (Pg. 3, Paragraph [0033]). The inorganic filler may be contained in an amount ranging from 60% by weight to 95% by weight (Pg. 7, Paragraph [0067]; Pg. 9, Paragraph [0086]). The inorganic fillers are mixed with an inorganic pigment in the range of 0.00001 to 1 part by weight (Pg. 6, Paragraph [0060]-[0061]).
Okada is silent with respect to the dental mill blanks satisfying conditions (1) and (2) as required by claim 1.
Okada is additionally silent with respect to the layers in the dental mill blanks satisfying condition (4).
However, the dental mill blanks which satisfy conditions (1) and (2), and further condition (4), appear to be dependent on the methods and materials of forming the dental mill blanks and one of ordinary skill in the art would recognize that a dental mill blank which is formed in a substantially identical method with the same materials would also have substantially identical properties. MPEP 2112.01(I): Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). MPEP 2112.01(II): "Products of identical chemical composition can not have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990).
In particular, the dental mill blanks of claim 1 are formed from an inorganic filler, such as silica, in a content range of 40% to 61% by weight with a average particle size of 30 to 700 nm (Pgs. 2-3, Paragraphs [0021]-[0025]). The inorganic filler may be surface treated and then mixed with an inorganic pigment in a range of 0.07 to 0.100 parts by weight based on 100 parts by mass of the inorganic filler (Pgs. 3-4, Paragraph [0026]-[0029]). The mixture is then combined with a polymerizable monomer and then cured (Pgs. 4-7, Paragraphs [0031]-[0068]). The dental mill blanks may be formed from press molding the compositions (Pg. 2, Paragraph [0021]; Pg. 8, Paragraph [0076]).
As discussed above, Okada teaches the dental mill blanks which are formed from press molding. Additionally, the composition which is press molded includes an inorganic filler in the range of 60% to 95% by weight with particle sizes in the range of 1 nm to 10000 nm (Pg. 3, Paragraph [0034]; Pg. 7, Paragraph [0067]; Pg. 9, Paragraph [0086]). The inorganic particles may be surface treated (Pgs. 7-8, Paragraph [0068]-[0079]). The surface-treated inorganic particles are then mixed with an inorganic pigment in the range of 0.00001 to 1 part by weight (Pg. 6, Paragraph [0060]-[0061]). The mixture is then allowed to contact a polymerizable monomer and then cured (Pgs. 10-14, Paragraphs [0088]-[0150]).
As indicated above, the materials and methods taught by Okada are substantially identical to those described in applicant’s specification. Therefore, one of ordinary skill in the art before the filing of the invention would have found it obvious that the dental mill blanks of Okada and those of applicant’s described invention would have substantially identical properties including satisfying conditions (1) and (2), and further condition (4), required by claim 1.
Okada further teaches the dental mill blanks may be press molded in a layered form (Pg. 7, Paragraphs [0066]-[0067]).
Okada is silent with respect to a different layer from above satisfying condition (3).
Goto teaches dental mill blanks which include a visually identifying portion in order to identify and ascertain the correct number of layers in the dental mill blank (Pg. 1, Paragraphs [0002]-[0007]). The visually identifiable portion may be present through the use of different colors, such as a cervical part color, a dentin color and an enamel color (Pg. 2, Paragraph [0011]). The different colors may be achieved through multiple layers of pastes having different colors (Pg. 2, Paragraph [0011]).
Therefore, it would have been obvious to one of ordinary skill in the art before the filing of the invention to form the dental mill blanks of Okada which have multiple layers formed from pastes having different colors, such as varying the inorganic pigment, in order to achieve a visually identifiable portion as taught by Goto. Additionally, it appears as though condition (3) required by the claim is dependent on the compositions of the dental mill blanks, and specifically the content of the inorganic pigment being in the range of 0.05 to 0.07 parts by weight (Instant Specification, PGPUB, Paragraph [0073]). As discussed above, Okada teaches substantially identical methods and materials including an inorganic pigment range of 0.00001 to 1 part by weight, which overlaps with the required range to satisfy condition (3). Therefore, one of ordinary skill in the art before the filing of the invention would have found it obvious that the dental mill blanks of Okada formed from multiple layers with different inorganic pigment contents would have one layer satisfying conditions (1) and (2) as discussed above and a separate layer which satisfies condition (3).
Regarding claim 4, Okada teaches the dental mill blanks as discussed above with respect to claim 1. As discussed above, the dental mill blanks include inorganic particles in a range of 1 to 10000 nm, which overlaps with the instantly claimed range. MPEP 2144.05: In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976).
Regarding claim 6, Okada teaches the dental mill blanks as discussed above with respect to claim 5. The inorganic pigments may be used in combinations of two kinds or more, which overlaps with the instantly claimed range.
Regarding claim 7, Okada teaches the dental mill blanks as discussed above with respect to claim 1. As discussed above, the dental mill blanks include inorganic particles in a range of 1 to 10000 nm, which overlaps with the instantly claimed range.
In addition to the rejections above, claims 1, 4 and 6-7 are rejected under 35 U.S.C. 103 as being unpatentable over Ishino (JP 2017-113224).
Regarding claim 1, Ishino teaches a method for forming a dental mill blank, and the resulting dental mill blanks, wherein the method comprises the steps of laminating a pre-polymerized curable composition to obtain a pre-polymerized laminate consisting of at least two layers; and a step of polymerizing the laminate wherein the curable compositions comprise an inorganic filler and a polymerizable monomer-containing composition (Paragraphs [0008]; [0084]). The inorganic filler may be any known material suitable for dental mill blanks, including silicon dioxide, and the filler may be present in an amount ranging from 40 to 95 mass % (Paragraphs [0029]; [0037]). The fillers may have a particle size ranging from 1 nm to 10 microns (Paragraph [0032]). The compositions further include an inorganic pigment which is present in an amount ranging from 0.00001 to 1 part by weight based on the content of the curable composition and the amount is adjusted in order to achieve a color difference between adjacent layers (Paragraphs [0024]-[0028]).
Ishino is silent with respect to the dental mill blanks satisfying conditions (1) and (2) as required by claim 1.
Ishino is additionally silent with respect to the layers in the dental mill blanks satisfying condition (4).
However, the dental mill blanks which satisfy conditions (1) and (2), and further condition (4), appear to be dependent on the methods and materials of forming the dental mill blanks and one of ordinary skill in the art would recognize that a dental mill blank which is formed in a substantially identical method with the same materials would also have substantially identical properties. MPEP 2112.01(I): Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). MPEP 2112.01(II): "Products of identical chemical composition can not have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990).
In particular, the dental mill blanks of claim 1 are formed from an inorganic filler, such as silica, in a content range of 40% to 61% by weight with a average particle size of 30 to 700 nm (Pgs. 2-3, Paragraphs [0021]-[0025]). The inorganic filler may be surface treated and then mixed with an inorganic pigment in a range of 0.07 to 0.100 parts by weight based on 100 parts by mass of the inorganic filler (Pgs. 3-4, Paragraph [0026]-[0029]). The mixture is then combined with a polymerizable monomer and then cured (Pgs. 4-7, Paragraphs [0031]-[0068]). The dental mill blanks may be formed from press molding the compositions (Pg. 2, Paragraph [0021]; Pg. 8, Paragraph [0076]).
As discussed above, Ishino teaches the dental mill blanks which are formed from stacking two or more polymerizable compositions and subsequently polymerizing the stack which are considered identical to the press molding methods. Additionally, the composition which is press molded includes an inorganic filler in the range of 40% to 95% by weight with particle sizes in the range of 1 nm to 10000 nm (Discussed above). The inorganic particles may be surface treated (Paragraphs [0038]-[0039]). The surface-treated inorganic particles are then mixed with an inorganic pigment in the range of 0.00001 to 1 part by weight (Discussed above). The mixture is then allowed to contact a polymerizable monomer and then cured (Paragraphs [0050]-[0083]).
As indicated above, the materials and methods taught by Ishino are substantially identical to those described in applicant’s specification. Therefore, one of ordinary skill in the art before the filing of the invention would have found it obvious that the dental mill blanks of Ishino and those of applicant’s described invention would have substantially identical properties including satisfying conditions (1) and (2), and further condition (4), required by claim 1.
Ishino is silent with respect to a different layer from above satisfying condition (3).
However, as discussed above, the adjacent layers of the blanks are formed to have a color difference which is affected by the content of the inorganic pigment and the inorganic filler. Furthermore, it appears as though condition (3) required by the claim is dependent on the compositions of the dental mill blanks, and specifically the content of the inorganic pigment being in the range of 0.05 to 0.07 parts by weight (Instant Specification, PGPUB, Paragraph [0073]). As discussed above, Ishino teaches substantially identical methods and materials including an inorganic pigment range of 0.00001 to 1 part by weight, which overlaps with the required range to satisfy condition (3). Therefore, one of ordinary skill in the art before the filing of the invention would have found it obvious that the dental mill blanks of Ishino formed from multiple layers with different inorganic pigment contents would have one layer satisfying conditions (1) and (2) as discussed above and a separate layer which satisfies condition (3).
Regarding claim 4, Ishino teaches the dental mill blanks as discussed above with respect to claim 1. As discussed above, the inorganic filler has a particle size from 1 nm to 10 microns, which overlaps with the claimed range.
Regarding claim 6, Ishino teaches the dental mill blanks as discussed above with respect to claim 1. The inorganic pigments may be used in combinations of two or more, which overlaps with the claimed 3 or more (Paragraph [0027]).
Regarding claim 7, Ishino teaches the dental mill blanks as discussed above with respect to claim 1. As discussed above, the inorganic filler has a particle size from 1 nm to 10 microns, which overlaps with the claimed range.
Response to Arguments
Applicant's arguments filed 05/13/2025 have been fully considered but they are not persuasive.
On pages 4-5, applicant argues that Okada and Goto are not combinable such that they require different methods. Specifically, Okada teaches a new method which does not include utilizing polymerizable pastes and curing the pastes which is taught by Goto.
The examiner does not find this argument persuasive such that the combination of Okada and Goto such that Goto is only relied upon to teach the various layers of Okada being visually identifiable from each other through the use of different colors (See rejection above). This rejection does not rely upon the use of a method in order to achieve the visually identifiable portions. As such, it would have been obvious to utilize different pigment concentrations in order to achieve visually identifiable layers rather than utilize a different method as argued by the applicant.
On pages 6-7, applicant argues that neither Okada nor Goto teaches each of the limitations of claim 1, including the new limitation of all of the layers satisfying a condition (4) which is a specimen with a thickness of 1.20 ± 0.01 mm has a chromaticity satisfying ∆b*≥ 17.0. Additionally, examples 5-7 illustrate when this condition is met and produces excellent opalescence quality, color tone reproducibility, and aesthetics on a black background. Comparative example 4 illustrates when this condition is not met by all layers and produces undesirable results which is considered equivalent to the blanks taught by the combination of Okada and Goto. As such, the blanks of Okada and Goto are not able to meet all four conditions required by claim 1.
The examiner first recognizes that none of the conditions are explicitly taught by either Okada or Goto. However, as noted above, the conditions are taught such that Okada teaches each of the required materials and teaches an overlapping range for the content of these materials. As such, one of ordinary skill in the art would recognize that each of the conditions would have been obvious in view of the teachings of Okada in view of Goto.
Concerning the examples and the comparative examples, the examiner recognizes that comparative example 4 fails to teach all layers satisfying the newly presented limitation concerning condition (4) and the resulting undesirable results. However, this condition appears to be dependent on the content of the inorganic pigment in at least one of the layers being between 0.070 and 0.100 parts by mass according to 100 parts by mass of the inorganic filler as claimed (See 35 U.S.C 112(b) rejection above). None of the layers in comparative example 4 have an inorganic pigment within this claimed range and, as such, it appears as though the ∆b* condition cannot be met.
The examiner further notes that the claimed range includes an upper end point range of 0.100 parts by mass. There are no examples which illustrate values of above this end point and it is further unclear as to how the inorganic pigment content above the upper end point of 0.100 parts by mass affects the ∆b* of condition (4).
Concerning applicant’s comparison of the dental mill blank of comparative example 4 and those of Okada and Goto, the examiner notes that the blanks of Okada include an inorganic pigment of between 0.00001 and 1 part by weight (See rejection above). This range overlaps with that of the claimed range of 0.070 to 0.100 parts by mass. As such, Okada includes the claimed range for the inorganic pigment and one of ordinary skill in the art would recognize the ∆b* of condition (4) is dependent on this content range. Therefore, one of ordinary skill in the art would recognize that the resulting overlapping inorganic pigment range results in an overlapping ∆b* range with condition (4). Ultimately, the examiner contends the newly presented condition is obvious in view of the teachings of Okada.
Lastly, upon a further search, a new rejection is presented in view of Ishino as discussed above which renders each of the limitations of claim 1 as obvious.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DANIEL P DILLON whose telephone number is (571)270-5657. The examiner can normally be reached Mon-Fri; 8 AM to 5 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, MARIA V EWALD can be reached at 571-272-8519. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DANIEL P DILLON/Examiner, Art Unit 1783
/MARIA V EWALD/Supervisory Patent Examiner, Art Unit 1783